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A Prospective Study to Compare the Clinical Outcomes, Pain and Patient Quality of Life for Hernia Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02715622
Recruitment Status : Active, not recruiting
First Posted : March 22, 2016
Last Update Posted : October 8, 2019
Sponsor:
Collaborator:
Accelovance
Information provided by (Responsible Party):
Intuitive Surgical

Brief Summary:

The objective of this prospective, multi-center post-market study is to prospectively collect uniform, evidence based outcomes for patients undergoing open, laparoscopic or robotic assisted hernia repair.

The outcomes that will be collected include various routine clinical parameters, short term patient reported outcomes (quality of life, pain scores) and long term hernia recurrence information. Patients will be treated according to standard of care at the surgeon's institution and patients will be followed up to collect information related to complications information and patient satisfaction associated with the hernia repair procedure.


Condition or disease Intervention/treatment
Hernia Incisional Hernia Hernia, Inguinal, Indirect Hernia, Inguinal, Direct Inguinal Hernia Procedure: Hernia repair

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Study Type : Observational [Patient Registry]
Actual Enrollment : 944 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: A Prospective, Multicenter Post-Market Study to Evaluate and Compare the Clinical Outcomes, Pain and Patient Quality of Life After Open, Laparoscopic or Robotic Assisted Hernia (Incisional and Inguinal) Repair
Study Start Date : April 2016
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Group/Cohort Intervention/treatment
Open Hernia Repair
A minimum of 300 patients will be enrolled in the Incisional and Inguinal Hernia open repair surgical procedure
Procedure: Hernia repair
Patient undergoing Hernia repair using different surgical modalities as per the surgeon's standard of care practice

Laparoscopic Hernia Repair
A minimum of 300 patients will be enrolled in the Incisional and Inguinal Hernia laparoscopic repair surgical procedure
Procedure: Hernia repair
Patient undergoing Hernia repair using different surgical modalities as per the surgeon's standard of care practice

Robotic Hernia Repair
A minimum of 300 patients will be enrolled in the Incisional and Inguinal Hernia robotic-assisted laparoscopic repair surgical procedure
Procedure: Hernia repair
Patient undergoing Hernia repair using different surgical modalities as per the surgeon's standard of care practice




Primary Outcome Measures :
  1. Number of complications observed intraoperatively through 30 days [ Time Frame: 30 days ]
    Number of intraoperative and short-term complications related to hernia repair.

  2. Number of patient reported complications post 30-days through 3 years post procedure [ Time Frame: 30 days post-procedure to 3 years post-procedure ]
    Number of long-term complications related to hernia repair directly reported by patients


Secondary Outcome Measures :
  1. Patient reported outcomes on Quality of Life through 1 year [ Time Frame: Pre-procedure (baseline) and 30 days through 1 year for Qualify of Life ]
    Use of quality of life questionnaires (Carolinas Comfort Scale or HerQles Abdominal Questionnaire) will be used to assess patient qualify of life pre-procedure and post-procedure through 1 year.

  2. Incisional or Inguinal Hernia Recurrence through 3 years [ Time Frame: 30 days post-procedure through 3 years ]
    Number of hernia recurrences for each patient will be patient reported through 3 years post-procedure.

  3. Patient reported outcomes on post-procedure pain through 3 years [ Time Frame: 2-4 weeks post-procedure through 3 years post-procedure ]
    Pain medication taken by patient (type, dosage and quantity of pills) will also be captured through patient reported methods. Unit of measure will be numerical count of pills take



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

At least 900 patients will be enrolled in this post-market study that is planned to be conducted for mainly 2 types of hernia repairs, Incisional hernia repair and inguinal hernia repair ( robotic-assisted, lap and open). Up to 2000 patients may be enrolled.

Approximately 450 patients who will undergo inguinal hernia repair across open, laparoscopic or robotic-assisted procedures (~ 150 patients in each surgical modality) and approximately 450 patients who will undergo incisional hernia repair across open, laparoscopic or robotic-assisted procedures (~ 150 patients in each surgical modality) will be enrolled in this study at up to thirty (30) study centers

Criteria

Inclusion Criteria:

  1. Age 18 years and older
  2. All patients undergoing either an open, laparoscopic or robotic-assisted
  3. Incisional or Inguinal Hernia repair procedure
  4. Non-Emergent Incisional or Inguinal Hernia Repair cases

Exclusion Criteria:

  1. Emergent Cases for both Incisional and Inguinal Hernia
  2. Incisional Hernia related to ostomy formation
  3. Incisional Hernia requiring component separation (determined pre-operatively or intraoperatively)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02715622


Locations
Show Show 17 study locations
Sponsors and Collaborators
Intuitive Surgical
Accelovance
Investigators
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Study Chair: Karl LeBlanc, MD Surgeon Group of Baton Rouge
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Intuitive Surgical
ClinicalTrials.gov Identifier: NCT02715622    
Other Study ID Numbers: ISI-PHS-2016
First Posted: March 22, 2016    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Hernia
Hernia, Inguinal
Incisional Hernia
Pathological Conditions, Anatomical
Hernia, Abdominal
Postoperative Complications
Pathologic Processes